IVUS Assessment of the Mechanism of In-stent Restenosis? Gary S. Mintz, MD Cardiovascular Research Foundation

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1 IVUS Assessment of the Mechanism of In-stent Restenosis? Gary S. Mintz, MD Cardiovascular Research Foundation

2 SURE Trial: Restenosis in non-stented lesions Average of the two image slices with the smallest pre- intervention and follow-up lumen CSA 2 p<.1 p<.5 p< p<.5 p<.5 p<.5 p<.5 EEM CSA P+M CSA Lumen CSA Pre Post 24 hrs 1 mo 6 mo 61 native vessel lesions (26 DCA, 35 PTCA) with complete serial IVUS studies (out of 79 lesions enrolled in the study) Kimura et al. Circulation 1997;96:475-83

3 Restenosis in Stented Lesions 4 2 IH or P&M CSA (mm 2 ) -2-4 stent or EEM CSA (mm 2 ) lumen CSA (mm 2 ) Proximal Reference Prox Edge Prox Body Central Distal Artic Body Distal Edge Distal Reference Hoffmann et al. Circulation 1996;94:

4 Therefore, in-stent restenosis is all intimal hyperplasia lumen CSA (mm 2 ) lumen CSA (mm 2 ) POST F/U -15 r= r= Stent CSA (mm 2 ) IH CSA (mm 2 ) Hoffmann et al. Circulation 1996;94:

5 % Analysis of 189 Consecutive Patients With Bare Metal In-stent Restenosis < >7.5 < >8 Stent CSA (mm 2 ) IH CSA/Stent CSA (%) % 4.4% of cases had "unrecognized mechanical complications" 12% had severe chronic stent underexpansion (<4.5mm 2 ) Castagna et al. AHJ 21;142:97-4

6 Impact of lesion length and final minimum stent area (MSA) on restenosis Restenosis MSA (mm 2 ) * * * * * * * * * 6 * 7.5 Length (mm) * * * * * * * * * * * * * * * ** *No actual observations in this range de Feyter et al. Circulation 1999;1:

7 Predictors of DES Thrombosis & Restenosis Underexpansion Edge problems (geographic miss, secondary lesions, large plaque burden, etc) DES Thrombosis Fujii et al. J Am Coll Cardiol 25;45:995-8) Okabe et al., Am J Cardiol. 27;1:615-2 Liu et al. JACC Cardiovasc Interv. 29;2: Fujii et al. J Am Coll Cardiol 25;45:995-8) Okabe et al., Am J Cardiol. 27;1:615-2 Liu et al. JACC Cardiovasc Interv. 29;2: DES Restenosis Sonoda et al. J Am Coll Cardiol 24;43: Hong et al. Eur Heart J 26;27: Doi et al. JACC Cardiovasc Interv. 29;2: Fujii et al. Circulation 24;19: Rathore et al. EuroIntervention 29;5: Sakurai et al. Am J Cardiol 25;96: Liu et al.am J Cardiol 29;13:51-6 Costa et al, Am J Cardiol, 28;11:

8 F/U MLA >4.mm 2 (%) Cypher in SIRIUS* 5. IVUS MSA (mm 2 ) By definition, sensitivity/specificity curve analysis must identify a single MSA that best separates restenosis from no restenosis This does NOT mean that mm 2 suffices in all pts/lesions. Angiographic restenosis (%) Angiographic restenosis (%) Cypher at AMC** *Sonoda et al. J Am Coll Cardiol 24;43: **Hong et al. Eur Heart J 26;27:135-1 ***Doi et al. J Am Coll Cardiol Intv 29 2: Honda & Fitzgerald. J Am Coll Cardiol Intv 29 2: TAXUS-IV, V, VI and ATLAS WH, LL, and DS (c-statistic=.64)*** IVUS MSA (mm 2 )

9 Predictors of angiographic restenosis in 55 pts with 67 native lesions treated with Cypher stents Angiographic restenosis (%) Angiographic restenosis (%) IVUS MSA (mm 2 ) IVUS total stent length (mm) <5.5mm 2 5.5mm 2 4mm 2.4%.4% >4mm 17.7% 8.6% Hong et al. Eur Heart J 26;27:135-1

10 The Optimal Cutoff Value of Post-Procedural MSA to Predict a Follow-up MLA 4mm 2 After Bifurcation T-Stenting AUC=.88 (95%CH=.8-.95) AUC=.81 (95%CH= ) Hahn et al. J Am Coll Cardiol 29;54:11-7

11 Manufacturer s Compliance Charts Cannot Be Used to Guarantee Adequate Stent Expansion Comparison of IVUS-measured minimum stent diameter (MSD) and minimum stent area (MSA) with the predicted measurements from Cordis (Cypher in yellow, n=133) and BSC (Taxus in red, n=67). DES achieve an average of only 75% of the predicted MSD (66% of MSA) IVUS Measured MSA (mm 2 ) IVUS Measured MSD (mm) Predicted MSA (mm 2 ) Predicted MSD (mm) (de Rebamar Costa et al, Am Heart J 27;153:297-33) 33)

12 Comparison of 9-month QCA edge restenosis vs reference lumen area and plaque burden in TAXUS- IV, V, and VI (n=81) ROC Plot ont AXUS Patients Edge Restenosis using Plaque Burden I ndex as the Predictor 1 True positive rate (Sensitivity) Reference lumen area did not affect Taxus edge Nodi scrimi nati on restenosis (c=.55) Reference plaque Pl aquebur den burden Index had a moderate effect on Taxus edge restenosis; a cut-off of 42% best separated edge restenosis from no restenosis (c=.67) False positiverate (1-S pecificity) (Liu et al, Am J Cardiol 29;13:51-6)

13 Underexpansion is often lumped with malapposition - even by people who should know better

14 Acute Incomplete DES Apposition and IH Persistent ISA (n=4, 83% decreased in size) Completely resolved ISA (n=15) CSA (mm 2 ) Post F/U CSA (mm 2 ) p=ns p=.1 p=.2 p=.9 Stent Intrastent Lumen IH ISA EEM Lumen P&M ISA IH* Max IH Persistent stent malapposition is associated with less intimal hyperplasia the drug can cross small stent vessel-wall gaps p=.6 p<.1 *at malapposition site (Hong et al. Circulation 26;113:414-9) (Kimura, et al. Am J Cardiol 26;98:436-42) 42) (Balakrishnan et al., Circulation 25;111: )

15 Serial angiographic FU of Palmaz- Schatz stents 3 yr FU Extended FU (7 11 yrs) RD MLD Kimura et al., N Engl J Med 1996;334:561-6 Kimura et al., Circulation 22;15:

16 Changes in Maximum Yellow Color Grade From Baseline to Follow-Up in DES Higo et al. J Am Coll Cardiol Img 29;2:616-24

17 Higo, T. et al. J Am Coll Cardiol Img 29;2:

18 Percentage of Patients With Atherosclerotic Changes in DES Versus BMS in Relation to Duration of Implant at Autopsy Nakazawa et al. J Am Coll Cardiol Img 29;2:625-8

19 BMS 57-month follow-up

20 Analysis of 2 stent fractures in 17 patients 15 stent fractures were detected by angiography and IVUS, and 5 were detected only by IVUS 15 stent fractures in 13 patients were associated with in-stent restenosis (all focal); and 2 stent fractures in 2 patients were associated with very late stent thrombosis Five stent fractures occurred within a coronary aneurysm accompanied by malapposition despite the absence of a coronary aneurysm at index stenting. Comparing stent fractures associated with an aneurysm to ones that did not occur in association with an aneurysm, complete stent fracture was more frequent (1% vs. 27%, p=.8), and all presented >1 year after index stenting (vs. 33%, p=.3). (Doi et al. Am J Cardiol 29;13:818-23)

21 Assessment of causes of in-stent restenosis Follow-up Baseline

22 A B C D E diastole systole diastole

23 mm

24 5. 15.mm

25 2.5 1.mm

26 DES after VBT failure for Rx of BMS Restenosis b a 2 years later c proximal

27 9-month minimum lumen area that predicts 3-year MACE-free survival in patients from TAXUS IV, V, and VI n=348 BMS C-statistic Cutoff Minimum lumen area.73 4.mm 2 n=351 Taxus C-statistic Cutoff Minimum lumen area mm 2 Doi et al. Circ Cardiovasc Intervent 28;1:111-8